Skip to main content
OpenTrials
Completed

NCT Number: NCT05722262

Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER and CSG452

The goal of this clinical trial is to demonstrate the bioequivalence of single oral administration of K-001 relative to single oral co-administration of separate tablets of K-877-ER and CSG452 in healthy adult volunteers, and to characterize the food effect on the Pharmacokinetics(PK) of K-001.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD - Austin Research Unit

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant provides written informed consent before any study-specific evaluation is performed.
  • Participant is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
  • Participant has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
  • Participant meet all other inclusion criteria outlined in the clinical study protocol.

Exclusion criteria

  • Participant has clinically significant abnormalities at Screening or at Check-in assessments, in the opinion of the investigator.
  • Participant is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug.
  • Participant meets any other exclusion criteria outlined in the clinical study protocol.

Treatment and study plan

K-001

Drug

K-877-ER and CSG452 combination tablet

K-877-ER

Drug

K-877-ER tablet

CSG452

Drug

CSG452 tablet

Primary outcomes

  1. Cmax of K-877 and CSG452

    Time frame: 1 hour before dosing and at multiple time points (up to 48 hours) post dose

    Maximum observed plasma concentration (Cmax) of K-877 and CSG452

  2. AUC0-t of K-877 and CSG452

    Time frame: 1 hour before dosing and at multiple time points (up to 48 hours) post dose

    Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)

  3. AUC0-inf of K-877-and CSG452

    Time frame: 1 hour before dosing and at multiple time points (up to 48 hours) post dose

    Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf).

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Official study title

A Randomized, Open-Label, Six-Sequence, Three-Period Crossover Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER Plus CSG452 in Healthy Adult Volunteers, and to Characterize the Food Effect on the Pharmacokinetics of K-001

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2023
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.